Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon Boyle

ORCID ID

Contact details

Orthopaedic Surgery
Leeds Teaching Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)7739 490649

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436151092

Study information

Scientific title

Acronym

Study hypothesis

The aim of this project is to ascertain the improvements in function and pain in patients with osteoarthritis of the knee, using valgus offloading knee braces. These braces are currently use for osteoarthritis within the department of orthopaedics in Leeds by some surgeons, however we do not have a prospective controlled trial to determine the benefit, if any, of using the braces available to us.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoarthritis of the knee

Intervention

Questionnaire; Randomised controlled trial

30/08/2012: Please note that this trial was abandoned before starting due to a lack of funding

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The patients will be assessed using one of the most internationally validated scoring systems, the WOMAC score, and also a Visual Analogue Pain Scale

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/06/2004

Overall trial end date

21/11/2005

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

The patients will be selected from new patient referrals seen in the orthopaedic outpatient clinic under Mr Calder at Leeds General Infirmary. They will be patients diagnosed with knee arthritis. If they fulfil the inclusion criteria then they will be given the option of taking part in the study and be consented accordingly.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Previous knee surgery in last 12 months
2. Arthritis other than OA
3. Hip disease
4. Previous tibial/femoral fracture
5. Morbid obesity BMI>35 (difficulty in brace fitting)
6. PVD or skin disorder preventing brace use

Recruitment start date

21/06/2004

Recruitment end date

21/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedic Surgery
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes